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Atazanavir or Lopinavir in HIV Post-exposure Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00385645
Recruitment Status : Completed
First Posted : October 11, 2006
Last Update Posted : March 31, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The study compares the adherence of 240 HIV-negative subjects randomly assigned to 2 different antiretroviral therapies for 28 days after accidental exposure to HIV.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Combivir+Kaletra Drug: Combivir+Reyataz Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of 2 Alternative Antiretroviral Combinations in HIV Post-exposure Prophylaxis: AZT-3TC (Combivir®) + Lopinavir-ritonavir (Kaletra®) Versus AZT-3TC (Combivir®)+ Atazanavir (Reyataz®). Multicentre, Prospective, Randomized, Open Study
Study Start Date : May 2006
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Proportions of patients completing 28-day antiretroviral treatment (ARVT)

Secondary Outcome Measures :
  1. Proportion of HIV-seropositive at 6 months
  2. Incidence of adverse effects (clinical and laboratory) during ARVT
  3. Adherence to ARVT, time to adherence loss.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18
  • HIV exposure requiring prophylaxis under current guidelines

Exclusion Criteria:

  • Pregnancy
  • Suspected drug resistance in source case
  • Contraindications to the study drugs
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00385645


Locations
Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Mutua de Terrassa
Terrassa, Barcelona, Spain, 08221
Hospital del Mar
Barcelona, Spain, 08003
Hospital de Sant Pau
Barcelona, Spain, 08025
Hospital Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic
Barcelona, Spain, 08036
Hospital Joan XXIII
Tarragona, Spain, 43007
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Felipe Garcia, MD Hospital Clinic of Barcelona
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felipe Garcia Alcaide, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00385645     History of Changes
Other Study ID Numbers: DATEM-PEP
First Posted: October 11, 2006    Key Record Dates
Last Update Posted: March 31, 2010
Last Verified: March 2010

Keywords provided by Hospital Clinic of Barcelona:
HIV seronegativity

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lopinavir
Atazanavir Sulfate
Lamivudine, zidovudine drug combination
Zidovudine
Lamivudine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Antimetabolites